Prospective Observational Study to Evaluate Physical Performance and Quality of Life in Older Long Stay Nursing Home Residents With Chronic Kidney Disease With and Without Anemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 815
- 主要终点
- Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
研究概览
简要总结
This is a prospective, multicenter, observational, hypothesis-generating study exploring mobility, Quality of Life and other physical performance measures among older, long-term stay Nursing Home residents with CKD, with versus without anemia. Enrolled patients will participate in the study up to a total of 26 weeks and be assessed at Weeks 1, 2, 14 and 26/End of Study. Based upon Week 1 hemoglobin and serum creatinine lab results, participants will be categorized into 1 of 4 groups.
详细描述
Study Design: Multicenter, non-interventional, 26-week, prospective, observational study of older, long-term stay residents with CKD, with and without anemia, in US Nursing Homes.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 65 years
- •Long-term resident of NH as documented in medical record by Director of Nursing (DON) or Medical Director or as indicated in Minimum Data Set (MDS) Section Q
- •Able to walk at least 1 step or propel wheelchair 1 revolution of wheel
- •Able to follow a one-step instruction
- •Written informed consent
排除标准
- •Admitted to NH for short stay rehabilitation (anticipated stay less than 3 months)
- •Receiving Renal Replacement Therapy (RRT)
- •Major surgery within the past 3 months
- •Life expectancy < 6 months or receiving palliative care
- •Currently enrolled in or has not yet completed at least 30 days since ending investigational device or drug study(s), or is receiving investigational agent(s)
- •Currently is enrolled in an interventional trial
- •Previously withdrawn from this study
结局指标
主要结局
Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
时间窗: Weeks 2, 14 and 26
The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).
次要结局
- Number of Participants With Anemia(Baseline)
- Percentage of Participants With Anemia Related Conditions at Baseline(Baseline)
- Estimated Glomerular Filtration Rate (GFR) for Participants With CKD(Weeks 1, 14 and 26)
- Physical Performance: Duration Walked or Wheeled at Each Visit(Weeks 2, 14, 26)
- Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit(Weeks 2, 14 and 26)
- Physical Performance: Time to Rise From Sitting to Standing(Weeks 2, 14, 26)
- Physical Performance: Grip Strength(Weeks 2, 14, 26)
- Physical Performance: Lower Extremity Strength, Left Leg.(Weeks 2, 14, 26)
- Physical Performance: Lower Extremity Strength, Right Leg(Weeks 2, 14, 26)